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United States Government Accountability Office:
GAO:
Report to the Secretary of Agriculture:
March 2012:
Food Safety:
Preslaughter Interventions Could Reduce E. coli in Cattle:
GAO-12-257:
GAO Highlights:
Highlights of GAO-12-257, a report to the Secretary of Agriculture.
Why GAO Did This Study:
Since 2006, the U.S. beef industry has recalled over 23 million pounds
of beef owing to contamination from pathogenic strains of Shiga toxin-
producing Escherichia coli (STEC) bacteria. These strains do not harm
cattle but may contaminate meat during slaughter. If humans eat
contaminated meat without properly cooking it, STEC can cause
illnesses, including bloody diarrhea and Hemolytic Uremic Syndrome,
which is characterized by kidney failure and can be fatal. The
Departments of Health and Human Services (HHS) and of Agriculture
(USDA) play a role in reducing STEC. USDA stated that interventions to
reduce STEC before slaughter offer a significant opportunity to
improve food safety.
GAO reviewed (1) interventions before slaughter that may help reduce
STEC in cattle; (2) USDA’s role in approving STEC vaccines; (3) the
extent to which STEC strains have been determined to be adulterants in
beef and the status of tests to detect them; and (4) practices, if
any, other countries have employed that could reduce STEC in cattle
and may be relevant to U.S. efforts. GAO reviewed documents; visited
cattle feedlots and a slaughter plant; and interviewed agency
officials, researchers, and industry and consumer group
representatives with expertise in STEC in cattle.
What GAO Found:
U.S. Department of Agriculture (USDA) and university researchers
identified several treatments administered before cattle are
slaughtered, or preslaughter interventions, that could reduce Shiga
toxin-producing Escherichia coli (STEC) in cattle. Such preslaughter
interventions include bacteriophages (viruses that infect and kill
bacteria), probiotics (live bacteria that can benefit the digestive
system), vaccines (biological preparations that alter the immune
system), and sodium chlorate (chemical that kills the STEC O157:H7
strain). However, few manufacturers have submitted applications for
preslaughter intervention products to target STEC according to
officials from USDA and the Food and Drug Administration. One
exception is for vaccines to reduce STEC O157:H7.
For preslaughter interventions, USDA exercises responsibilities for
licensing and regulating STEC vaccines. However, USDA’s approval
requirements for these vaccines are unclear, according to some
industry representatives. Specifically, USDA’s general guidance does
not address some of the unique challenges faced by manufacturers of
animal health products seeking STEC vaccine approval. For example, the
guidance does not explain that, if studies conducted in the laboratory
are insufficient to demonstrate efficacy, the manufacturer would also
need to demonstrate that the vaccine is effective in a field setting
such as a feedlot. In contrast, the Canadian Centre for Veterinary
Biologics provides more specific guidance about when it requires the
use of laboratory or field studies to demonstrate efficacy for vaccine
license applications. Without guidance that gives manufacturers clear
and more specific information they need to submit for an acceptable
application, the approval process for STEC vaccines could face
potential delays.
In addition to STEC O157:H7, which it stated in 1994 was an adulterant—
a substance that renders food injurious to human health—in September
2011, USDA determined that six other STEC strains were adulterants in
raw ground beef and beef trim (meat left after steaks and roasts are
cut from beef). USDA has tests for these six strains and plans to use
them in slaughter plants starting in June 2012. However, it may be
difficult and time-consuming to confirm positive test results because
certain test components are either not commercially available for all
strains or do not always provide clear results. USDA is working to
improve the tests and to find a commercial supplier for one key test
component. Also, a few companies voluntarily test for these strains.
Some foreign governments have practices that could be relevant to U.S.
efforts to reduce STEC in cattle such as the following:
* The European Parliament and the Council of the European Union
require certain measures, such as verification of cleanliness by an
inspector, to ensure that the cattle going to slaughter are clean. In
contrast, USDA assesses the health of cattle but does not inspect for
cleanliness.
* At least 12 European Union member countries collected and reported
data on STEC in live cattle in 2009. USDA has conducted STEC testing
in live cattle, but has not tested since 1999.
* When a person becomes ill from E. coli in Sweden, government
officials try to determine the specific farm that sold the
contaminated cattle so that other carcasses from the farm can be
tested for STEC. USDA does not trace the STEC source back to the farm.
What GAO Recommends:
GAO recommends, among other things, that USDA provide more specific
public guidance on the license approval requirements of STEC vaccines.
USDA neither agreed nor disagreed with this recommendation.
View [hyperlink, http://www.gao.gov/products/GAO-12-257] or key
components. For more information, contact Lisa Shames at (202) 512-
3841 or shamesl@gao.gov.
[End of section]
Contents:
Letter:
Background:
Several Interventions Could Reduce STEC in Cattle:
USDA Exercises Responsibility for Approving STEC Vaccines, but Its
Approval Requirements Are Unclear:
USDA Determined That Six Additional STEC Strains Were Adulterants and
Has Tests to Detect Them:
Some Countries Have Practices That Could Be Relevant to U.S. Efforts
to Reduce STEC in Cattle:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Objectives, Scope, and Methodology:
Appendix II: Comments from the U. S. Department of Agriculture:
Appendix III: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: Agencies with Responsibilities Related to STEC Contamination
in Beef:
Table 2: Approval Status and Challenges for Preslaughter Interventions:
Figures:
Figure 1: STEC O157:H7 Bacteria:
Figure 2: Beef Production Process:
Figure 3: Preliminary and Isolation and Confirmation Testing Phases
for the Six STEC Non-O157 Strains:
Abbreviations:
APHIS: Animal and Plant Health Inspection Service:
ARS: Agriculture Research Service:
CDC: Centers for Disease Control and Prevention:
FDA: Food and Drug Administration:
FSIS: Food Safety and Inspection Service:
HACCP: Hazard Analysis and Critical Control Point:
HHS: Department of Health and Human Services:
NIFA: National Institute of Food and Agriculture:
STEC: Shiga Toxin-Producing Escherichia coli:
USDA: U.S. Department of Agriculture:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
March 9, 2012:
The Honorable Thomas J. Vilsack:
Secretary of Agriculture:
Dear Mr. Secretary:
Since 2006, the U.S. beef industry has recalled over 23 million pounds
of beef because of contamination from pathogenic strains of Shiga
toxin-producing Escherichia coli (STEC). These bacterial STEC strains
can live in the intestines or on the hide of cattle without harming
them, but they may contaminate meat during the slaughter process. If
humans then consume the contaminated meat without properly cooking it,
STEC strains can cause illnesses, including bloody diarrhea and
Hemolytic Uremic Syndrome, which is characterized by kidney failure
and can be fatal. The Centers for Disease Control and Prevention (CDC)
does not have estimates specific to beef, but it estimates that STEC
contamination of food consumed domestically causes approximately
176,000 illnesses, 2,400 hospitalizations, and 20 deaths annually.
Illnesses caused by STEC O157:H7, the most common STEC strain in the
United States, cost those infected $489 million annually, in 2010
dollars, according to an estimate from the U.S. Department of
Agriculture (USDA).
In addition to STEC O157:H7, over 150 other STEC strains can cause
illness. In this report, we refer to these strains as STEC non-O157,
and CDC has identified six common groups of such strains that cause
approximately 113,000 illnesses in the United States each year. These
strains are known as O26, O45, O103, O111, O121, and O145.
USDA's Food Safety and Inspection Service (FSIS) is responsible for
examining and inspecting the carcasses and parts of cattle at
slaughter plants and meat processing plants that will be used for
human consumption. The Federal Meat Inspection Act prohibits the sale
of adulterated meat or meat products--products bearing or containing a
poisonous or deleterious substance that may render them injurious to
human health, among other things--and provides FSIS with the authority
to prescribe rules and regulations concerning the sanitation at
slaughter plants and meat-processing plants. In 1994, FSIS stated that
it considered STEC O157:H7 an adulterant in ground beef, which
according to a USDA report, is the most frequently implicated source
of STEC O157:H7 outbreaks in the United States. FSIS's inspection
authority does not extend to the feedlot, where most cattle are fed
grain for about 140 days prior to slaughter, but the agency encourages
beef producers to use preslaughter interventions, such as vaccinating
the animal against STEC, to control STEC O157:H7. FSIS has stated that
such interventions offer a significant opportunity to improve food
safety because they may reduce the level of STEC entering the
slaughter plant. The beef industry generally supports researching and
developing these interventions and has funded many intervention
activities for possible future use.
In this context, we reviewed USDA's and others' efforts to reduce STEC
contamination in beef. Our objectives were to identify (1)
preslaughter interventions--that is, treatments administered before
cattle are slaughtered that can target STEC--that may help reduce STEC
in cattle; (2) USDA's role in approving STEC vaccines; (3) the extent
to which STEC strains have been determined to be adulterants in beef
and the status of tests to detect them; and (4) practices, if any,
other countries have employed that could reduce STEC in cattle and may
be relevant to U.S. efforts.
For all four objectives, we visited several cattle feedlots and a
cattle slaughter plant in Colorado, which we selected because it is
one of the largest beef producing states, and interviewed USDA
officials, beef industry representatives, and university researchers
in Colorado. In addition, using a nonprobability sample, we conducted
a total of 71 interviews with USDA, CDC, and Food and Drug
Administration (FDA) officials; foreign government officials; beef
industry representatives; manufacturers of animal health products;
federal and university researchers; and consumer group representatives
with expertise in STEC in cattle. Because this was a nonprobability
sample, the results cannot be generalized to the entire United States,
but can provide examples of research conducted on preslaughter
interventions. To determine the preslaughter interventions that may
help reduce STEC in cattle, we reviewed USDA and academic studies on
preslaughter interventions, reviewed USDA documents on funding for
STEC research, and met with USDA and university researchers and beef
and pharmaceutical industry representatives. To determine USDA's role
in approving STEC vaccines, we reviewed USDA guidance and interviewed
USDA officials, manufacturers of animal health products, and
university researchers. To determine the extent to which STEC strains
have been determined to be adulterants in beef and the status of tests
to detect them, we reviewed USDA documents on STEC detection tests and
interviewed FDA and USDA officials, beef industry representatives, and
detection test manufacturers. To determine practices, if any, other
countries have employed that could reduce STEC in cattle and may be
relevant to U.S. efforts, we asked CDC, FDA, and USDA officials; beef
industry representatives; university researchers; and consumer group
representatives if they were aware of any such practices. We also
reviewed international studies, guidance, and requirements for food
safety in beef and interviewed international food safety officials.
Appendix I contains an expanded explanation of our objectives, scope,
and methodology.
We conducted this performance audit from January 2011 to March 2012 in
accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe
that the evidence obtained provides a reasonable basis for our
findings and conclusions based on our audit objectives.
Background:
This section discusses STEC and agencies that play a role in reducing
STEC contamination.
Shiga Toxin-Producing E. coli:
E. coli bacteria live in the intestines of healthy cattle and have a
symbiotic relationship with the cattle, an association in which the E.
coli derives the benefit, and cattle are not harmed. The organism has
been found in young beef calves and older cows, as well as in dairy
calves and dairy cows. E. coli tends to colonize at the end of a cow's
intestinal system, in an area known as the anorectal junction. A cow
with E. coli in its intestinal system typically "sheds" the organism
through its feces. As cattle shed E. coli, the bacteria can
contaminate the hides and then the meat as the cattle are slaughtered.
Several strains of E. coli have evolved to being highly pathogenic and
capable of causing death when they infect humans.
STEC O157:H7, pictured in figure 1, is the strain of STEC bacteria of
primary interest to USDA and researchers. STEC O157:H7 was first
recognized as a disease-causing organism in 1982 and became a research
priority in 1993, when over 700 people were affected after eating
undercooked hamburgers at a fast-food restaurant chain. This outbreak
was the largest reported outbreak in North America, and 55 patients,
including 4 children who died, developed Hemolytic Uremic Syndrome.
Symptoms of STEC O157:H7 can also include severe bloody diarrhea,
profuse bleeding, seizures, kidney failure, coma, and death.
Figure 1: STEC O157:H7 Bacteria:
[Refer to PDF for image: photograph]
Source: CDC.
[End of figure]
In 1994, USDA's FSIS made public that it considered STEC O157:H7 as an
adulterant in raw ground beef; it established a zero-tolerance policy
for this pathogen in this food product and began a sampling program to
test for the pathogen in federally inspected establishments and retail
stores. FSIS also made public that it would use available enforcement
tools, such as requesting a recall from beef producers if the product
had entered commerce. Any raw ground beef found to contain STEC
O157:H7 must be disposed of or sent for further processing that
involves a "lethality step," such as cooking the meat before selling
it.[Footnote 1]
Under current law, thousands of FSIS regulatory inspectors maintain
continuous inspection at slaughter facilities and examine all
slaughtered meat carcasses. Inspectors also visit other meat-
processing facilities at least once each operating day. In 1996, FSIS
established Hazard Analysis and Critical Control Point (HACCP) system
requirements for all processing plants. The HACCP system requires that
plants identify biological, chemical, and physical food safety hazards
that are reasonably likely to occur and develop and implement plans to
prevent and control those hazards.
In addition to STEC O157:H7, CDC has identified six groups of STEC
strains--O26, O45, O103, O111, O121, and O145--that are also
pathogenic. These STEC non-O157 strains have been found in ground beef
and on cattle hides and feces at levels comparable to those for STEC
O157:H7, and they have been found to cause the same human illnesses.
In 2010, for the first time, the number of laboratory-confirmed STEC
infections from strains other than STEC O157:H7 was greater than the
number of STEC O157:H7 infections.
Agencies that Play a Role in Reducing STEC Contamination:
Two federal departments are primarily responsible for ensuring the
safety of the U.S. food supply, including the prevention of STEC
contamination--USDA and the Department of Health and Human Services
(HHS). Each department contains agencies that contribute to the
national effort to assess, measure, and track STEC contamination (see
table 1).
Table 1: Agencies with Responsibilities Related to STEC Contamination
in Beef:
Department and agency: USDA; Food Safety and Inspection Service;
Responsibilities related to STEC contamination in beef: Regulates the
safety, wholesomeness, and proper labeling of domestic and imported
meat under authority of the Federal Meat Inspection Act.[A] Inspects
slaughter plants, processing plants, and import establishments in the
United States and can keep some products from entering the food supply
via meat inspections at the plant level. May not mandate recalls of
contaminated meat but does provide assistance and monitors voluntary
recalls by the beef industry. Provides guidance to the beef industry
regarding best practices for reducing STEC contamination.
Department and agency: USDA; Animal and Plant Health Inspection
Service (APHIS);
Responsibilities related to STEC contamination in beef: Protects U.S.
livestock and poultry from domestic and foreign diseases and pests
under the Animal Health Protection Act.[B] Reviews and approves
applications for biological product licenses, such as vaccines, that
could be used as part of a STEC preslaughter intervention. Manages the
National Animal Health Monitoring System--a periodic, national survey
of producers that focuses on management practices and animal health in
feedlots.
Department and agency: USDA; Agricultural Research Service (ARS);
Responsibilities related to STEC contamination in beef: Conducts
research on a variety of STEC-related issues, such as prevention of
STEC colonization in cattle, interventions to reduce STEC in beef, and
STEC strain detection methods.
Department and agency: USDA; National Institute of Food and
Agriculture (NIFA);
Responsibilities related to STEC contamination in beef: Funds research
on the prevention, detection, and colonization of STEC in cattle
through grants to universities and other organizations.
Department and agency: HHS; FDA;
Responsibilities related to STEC contamination in beef: Regulates the
manufacture and distribution of food, food additives, and drugs for
humans and animals under the Federal Food, Drug and Cosmetic Act.[C]
Ensures the safety and effectiveness of animal drugs, including those
intended to reduce STEC prevalence in cattle, such as sodium chlorate.
Department and agency: HHS; CDC;
Responsibilities related to STEC contamination in beef: Routinely
gathers information from local and state health departments and
laboratories and reports information about human STEC infections and
the foods with which they are associated.
Source: GAO.
[A] 21 U.S.C. §§ 601-683.
[B] 7 U.S.C. §§ 8301-8322.
[C] 21 U.S.C. §§ 301-399d.
[End of table]
Several steps are involved in getting cattle from the farm to the
consumer. Often, USDA and FDA provide regulatory oversight after the
cattle leave the farm or feedlot and arrive at slaughter plants and
food handling and manufacturing facilities. Figure 2 illustrates the
beef production process from the farm to the consumer.
Figure 2: Beef Production Process:
[Refer to PDF for image: illustration]
Farm:
Feedlot:
Slaughter plant:
Restaurant: Restaurant preparation: Restaurant customer;
Retail: Homer preparation: Home consumers.
Source: CDC and GAO.
[End of figure]
In 2007, GAO designated federal oversight of food safety as a high-
risk area because of risks to the economy and to public health and
safety. As GAO has reported, the current fragmented system has caused
inconsistent oversight, ineffective coordination, and inefficient use
of resources.[Footnote 2]
Several Interventions Could Reduce STEC in Cattle:
USDA and university researchers identified several potential
preslaughter interventions--including probiotics, sodium chlorate, and
vaccines--that could reduce STEC O157:H7 in cattle and, in some cases,
may have potential for reducing other strains of STEC. USDA conducts
and funds research relevant to these interventions, including research
on the prevalence of STEC and on the interventions themselves.
Researchers Identified Preslaughter Interventions That Could Reduce
STEC in Cattle:
Preslaughter interventions are treatments administered before cattle
are slaughtered that can target STEC, usually the O157:H7 strain. Some
interventions, such as sodium chlorate and vaccines, may also reduce
other pathogenic strains, but researchers have not conducted testing
for the effects of interventions on other strains. According to
representatives for a beef industry group, most research on
preslaughter interventions has focused on those administered at the
feedlots, although they may also be administered in the holding pen of
a slaughter plant. Preslaughter interventions are not likely to
eliminate STEC O157:H7 in cattle; instead, the goal is to reduce the
pathogen to levels that the HACCP systems at slaughter plants are able
to control effectively, according to beef industry representatives and
researchers. They also said that multiple interventions are needed to
accomplish this. Some studies suggest that a few interventions are
effective in reducing STEC O157:H7 in the digestive systems or on the
hides of cattle, but it may be difficult to demonstrate that they
reduce the levels of STEC O157:H7 in beef, according to manufacturers
of animal health products and researchers.
USDA and university researchers we spoke with identified several
potential preslaughter interventions for reducing STEC O157:H7 and, in
some cases, these interventions may have potential for reducing other
strains of STEC. Some of these interventions are in use for other
purposes, but few manufacturers have submitted applications for
preslaughter intervention products to target STEC--with the exception
of bacteriophages (viruses that infect and kill bacteria) and
vaccines--according to officials from USDA and FDA. The following are
the interventions that researchers identified, along with challenges
for bringing these interventions to market:
* Antimicrobials. These are drugs used to treat infections by
microorganisms, such as bacteria and viruses, and include synthetic
and natural antibiotics. Antibiotics are currently used in cattle to
treat or prevent diseases and increase growth. According to some
researchers, it may not be feasible for industry to use antibiotics as
a preslaughter intervention to reduce STEC because of concerns that
such use will lead to greater prevalence of bacteria that are
resistant to antibiotics. If resistant bacteria were to reach humans
and cause illness, this illness might be more difficult to treat.
Researchers also said that, for the same reason, it is unlikely that
the veterinary pharmaceutical industry would pursue requesting
approval for antibiotics as a preslaughter intervention. In April
1999, we reported that according to scientists, resistant strains of
E. coli found in humans acquired resistance to antibiotics while in
food animals.[Footnote 3] Resistant strains of E. coli may be
transferred to humans through food or through contact with animals or
animal waste.
* Bacteriophages. These naturally occurring viruses infect bacteria
and are highly specific--each type typically can kill a single strain
or species of pathogenic bacteria. USDA, in consultation with FDA,
licensed a mixture of bacteriophages that may be applied to cattle
hides in holding pens at slaughter plants. Other bacteriophages, which
could be administered orally, are at the experimental stage. According
to researchers, it is possible for STEC O157:H7 to become resistant to
some bacteriophages.
* Colicins. These antimicrobial proteins are produced by certain STEC
strains and can kill other strains. According to researchers, studies
to date on the use of colicins to reduce STEC in cattle are few, and
colicins are difficult to produce and expensive to use in studies.
* Natural product extracts. These are compounds that are generally
extracted from spices, aromatic herbs, fruits, and flowers, but can
also be obtained from other natural products, such as marine plants.
In particular, essential oils--a type of natural product extract--
demonstrate antimicrobial activity that may reduce STEC O157:H7,
according to researchers. Studies on the effect of essential oils on
STEC O157:H7 in cattle are limited to the laboratory, but USDA and
university researchers are developing field trials of citrus by-
products, such as orange peel, which contain essential oils. Some
compounds, or the products from which they are extracted, such as
orange peel and brown seaweed extract, are currently used in cattle
feed in some feedlots. Research is unclear on how much of the
compounds or the products from which they are extracted, such as
citrus and thyme oils, will pass through the cattle's stomach, and it
may be challenging to obtain a large quantity of these compounds to
feed to cattle on a commercial basis, according to researchers.
* Prebiotics. These nondigestible organic compounds can promote the
growth and activity of beneficial bacteria in the digestive system of
cattle, which in turn can reduce the prevalence of bacterial
pathogens. According to USDA researchers, little work has been
conducted on the effects of these compounds on STEC O157:H7 in cattle.
Furthermore, the compounds may be expensive to use in cattle and may
not pass through the cattle's stomach.
* Probiotics. These are live bacteria that can benefit the digestive
system of cattle. According to USDA researchers, probiotics can
prevent harmful colonization by bacteria by producing antibacterial
compounds or by promoting healthy immune function. Researchers have
conducted field trials to test whether varying amounts of certain
probiotic strains reduce STEC O157:H7. Probiotics are widely used to
increase weight gain. According to a few researchers, in order for
probiotics to reduce STEC O157:H7, cattle may need to be fed large
quantities, which may be costly to producers.
* Sodium chlorate. This chemical kills STEC O157:H7 when it transforms
to toxic chlorite inside the bacterial cell. This transformation
occurs in both the stomach and the intestinal tract of cattle.
According to representatives for a veterinary pharmaceutical
manufacturer, the manufacturer is discussing with FDA applying for
approval of sodium chlorate as an animal drug. According to a few
researchers, it is likely that sodium chlorate would also reduce STEC
non-O157.
* Vaccines. These are biological preparations that alter the immune
system to better fight specific pathogens. At least two manufacturers
of animal health products have developed vaccines to target STEC
O157:H7 in cattle and are seeking approval from APHIS to market them.
One of these manufacturers received a conditional license for a
vaccine in 2009 and, according to representatives from these
manufacturers, applications for full licenses for two vaccines are
pending.[Footnote 4] According to a few researchers and
representatives for a veterinary pharmaceutical manufacturer,
administering higher doses of a vaccine would increase its efficacy
but may be costly. For example, handling the cattle to specifically
administer a STEC vaccine may increase labor costs. USDA officials
also said that cattle producers may not directly benefit from
administering these vaccines. Additionally, according to one
university researcher and one animal health product manufacturing
official, vaccines have the potential to reduce STEC non-O157, but a
vaccine study of STEC non-O157 has not been conducted on animals.
APHIS officials told us that they have not received information that
could support this theory.
Table 2 provides a summary of preslaughter interventions, their
approval status, the agency responsible for their approval, and
challenges for the use of intervention.
Table 2: Approval Status and Challenges for Preslaughter Interventions:
Preslaughter intervention: Antimicrobials;
Approved for use to reduce STEC O157:H7 in cattle: No;
Agency responsible for approval: FDA;
Challenges for use of intervention: STEC O157:H7 may become resistant.
Preslaughter intervention: Bacteriophages;
Approved for use to reduce STEC O157:H7 in cattle: Yes[A];
Agency responsible for approval: USDA FDA;
Challenges for use of intervention: STEC O157:H7 may become resistant.
Preslaughter intervention: Colicins;
Approved for use to reduce STEC O157:H7 in cattle: No;
Agency responsible for approval: FDA;
Challenges for use of intervention: Expensive and difficult to produce.
Preslaughter intervention: Natural product extracts;
Approved for use to reduce STEC O157:H7 in cattle: No;
Agency responsible for approval: FDA;
Challenges for use of intervention: May not pass the cattle's stomach
and may be difficult to obtain in large quantities.
Preslaughter intervention: Prebiotics;
Approved for use to reduce STEC O157:H7 in cattle: No;
Agency responsible for approval: FDA;
Challenges for use of intervention: May be costly and may not pass the
cattle's stomach.
Preslaughter intervention: Probiotics;
Approved for use to reduce STEC O157:H7 in cattle: No;
Agency responsible for approval: FDA;
Challenges for use of intervention: Cattle may need to be fed large
amounts to reduce STEC.
Preslaughter intervention: Sodium chlorate;
Approved for use to reduce STEC O157:H7 in cattle: No;
Agency responsible for approval: FDA;
Challenges for use of intervention: None[C].
Preslaughter intervention: Vaccines;
Approved for use to reduce STEC O157:H7 in cattle: Yes[B];
Agency responsible for approval: USDA;
Challenges for use of intervention: Cost associated with specifically
administering a STEC vaccine.
Source: GAO analysis of interviews with USDA officials, FDA officials,
and university researchers.
[A] USDA, in consultation with FDA, licensed a bacteriophage hide wash
to be applied at the slaughterhouse prior to slaughter. Bacteriophages
could also be administered orally, but FDA has not licensed any such
product.
[B] USDA granted conditional approval to one vaccine manufacturer.
[C] Researchers we spoke with did not identify challenges when we
asked them to discuss the challenges or roadblocks for each
intervention. This does not mean that the intervention is without
challenges, because there may be challenges that researchers are not
aware of.
[End of table]
USDA, the beef industry, and several researchers also identified
preslaughter management practices that may affect STEC prevalence in
cattle but that are not targeted to STEC. For example, basic
sanitation practices--such as providing clean feed and water and
keeping feedlots drained--have been identified by the beef industry
and USDA as important steps in reducing the risk of STEC contamination
in beef products. These practices are believed to be beneficial for
the cattle's health and welfare, although they have not been shown to
be effective in reducing the pathogen, according to the beef industry
and a USDA study. Researchers from one university noted interest in
testing the effects of this and other preslaughter practices on STEC
in cattle.
Another preslaughter management practice researchers identified is
diet modification, which includes modifying feed type, from feed grain
to grasses, or the reverse; the frequency of feeding; and the quality
of the grasses. Researchers have examined diet modification's effect
on the prevalence of STEC O157:H7 but have not reached a consensus
about it. For example, some researchers have found that a diet with
distillers grains--a co-product of the production of ethanol from
corn--increases STEC O157:H7 prevalence in cattle, but others have
found that it has no effect. Furthermore, according to several USDA
and university researchers, diet modification may not be practical for
reducing STEC O157:H7 in cattle, partly because of the potentially
high cost.
USDA Has Funded and Conducted Relevant Research:
USDA has funded and conducted research on STEC prevalence in cattle,
as well as research specific to preslaughter interventions. In fiscal
years 2009 and 2010, USDA's NIFA, through its Agriculture and Food
Research Initiative, approved approximately $35 million in research
grants related to understanding and reducing STEC prevalence in
cattle. NIFA provided a total of about $28 million in five grants for
research on how preslaughter interventions may reduce STEC in cattle,
a total of about $5 million in three grants for research on how STEC
behaves in the digestive system of cattle, and about $2.5 million for
one grant for research on both preslaughter interventions and the
behavior of STEC in the digestive system of cattle.
In addition, USDA's ARS has worked closely with other USDA agencies,
university researchers, and pharmaceutical manufacturers to research
the prevalence of STEC in cattle's digestive systems and potential
preslaughter interventions, according to ARS officials. For example,
these officials said that ARS has conducted research on "super-
shedders," which are cattle that appear to shed more STEC than other
cattle in the same herd. Regarding preslaughter interventions, ARS
researchers have investigated the effect of sodium chlorate on STEC in
the digestive system and, according to agency officials, ARS has
collaborated with companies to develop preslaughter interventions such
as prebiotics, bacteriophages, and sodium chlorate.
USDA Exercises Responsibility for Approving STEC Vaccines, but Its
Approval Requirements Are Unclear:
USDA's APHIS exercises responsibility for licensing and regulating
animal biologic products that diagnose, prevent, manage, cure, or
otherwise treat diseases of animals, including vaccines that can be
used as a preslaughter intervention. Industry representatives have
identified at least two manufacturers of animal health products that
have each submitted an application to APHIS for approval of a STEC
vaccine to treat the O157:H7 strain in cattle, and USDA announced the
approval of a conditional license for one of these manufacturers.
According to representatives from two manufacturers of animal health
products that sought a license for STEC O157:H7 vaccines, it was
unclear whether FDA or USDA was responsible for reviewing and
approving their applications when they wanted to apply in 2001 and
2003. It took more than a year before APHIS accepted their
applications for review, in part because of lack of clarity over
whether FDA or APHIS should be responsible for approving such
vaccines, according to these representatives. Specifically, APHIS is
responsible for regulating vaccines that diagnose, prevent, manage,
cure, or otherwise treat diseases of animals, but APHIS officials told
us that because STEC O157:H7 does not harm cattle, the agency had
found prior to 2005 that regulatory jurisdiction for STEC O157:H7
vaccines resided with FDA as a food safety issue. According to these
officials, the manufacturers of animal health products told them that
the licensing process would be clearer under APHIS because it had more
experience regulating conventional veterinary vaccines than FDA.
In 2005, APHIS stated its policy on animal vaccines in a directive
explaining that it was responsible for regulating biological products
such as the STEC O157:H7 vaccine.[Footnote 5] Specifically, the
directive stated that APHIS had the authority to approve products that
claim to reduce colonization or shedding of organisms that may not
cause significant clinical disease in animals but have the potential
to cause the animal to be a disease carrier. According to an FDA
official, if a manufacturer contacts FDA's Office of New Animal Drug
Evaluation seeking a license for a STEC O157:H7 vaccine product, this
office assists APHIS by immediately directing the manufacturer to
APHIS. The APHIS directive expired as guidance in 2006, but because
APHIS has not issued any subsequent statements on this policy, an
APHIS official said that the policy in the directive remains in
effect. This 2005 directive clarified APHIS's approval authority and
role concerning vaccine approvals, but APHIS's approval requirements
for STEC vaccines are not clear, according to industry representatives.
APHIS officials said that they direct potential applicants for STEC
vaccine licensing to both the agency's general guidance on
demonstrating the safety and efficacy of biological products and to
its 2005 directive.[Footnote 6] According to an APHIS official, the
STEC vaccine is one of the most difficult vaccines for which to show
definitive, consistent, and reproducible efficacy results. However,
APHIS's general guidance does not address this and other unique
challenges faced by manufacturers of animal health products seeking
STEC vaccine approval. For example, APHIS officials said that a STEC
vaccine manufacturer may need to demonstrate that its vaccine is
effective in a field setting--such as a feedlot in which cattle can be
naturally exposed to pathogens--if studies conducted in the laboratory
in which cattle are intentionally exposed to pathogens are
insufficient to demonstrate efficacy. With other vaccines, a
laboratory study is often sufficient because it can demonstrate
consistent efficacy. However, information on when laboratory and field
studies are required to demonstrate efficacy is not documented in the
general guidance or 2005 directive. In contrast, the Canadian Centre
for Veterinary Biologics provides more specific guidance about when it
requires the use of laboratory or field studies to demonstrate
efficacy for vaccine license applications. In addition, neither the
2005 directive nor APHIS's general guidance provides clear, specific
instruction to manufacturers on the application process for STEC
vaccines. For example, the 2005 directive states that the vaccine
products will be required to show "clinically relevant efficacy as
defined by APHIS" but does not explain what such efficacy means.
According to an APHIS official, "clinically relevant efficacy" is the
expectation that the vaccine's efficacy is measurable, reproducible,
consistent, and shows a long-term effect in reducing the disease in
the animal, but this clarification is not specified in written
guidance. Guidance that does not give manufacturers the information
they need to submit an acceptable application could delay the approval
process even with the clarification on APHIS's role concerning vaccine
approvals.
More specific guidance on the vaccine approval requirements may be
especially important to manufacturers of animal health products
working on STEC because of the challenges they face in demonstrating
the efficacy of targeted preslaughter interventions. This difficulty
is due to several biological factors specific to STEC, according to
USDA officials, industry representatives, and university researchers.
First, the prevalence of STEC is highly variable. For example,
researchers said that STEC can be absent from cattle--or present only
at low levels--during a field trial at a feedlot. That is, both
treated and untreated cattle can have little or no detectable STEC,
and thus it can be difficult for researchers to demonstrate that
treated cattle have significantly lower levels of the pathogen.
Second, many factors--such as weather, the time of year, and the
cleanliness of the cattle's hide--may affect the level of pathogenic
STEC in cattle, making it difficult to isolate the effects of an
intervention. Third, unlike other pathogens, STEC causes no visible
symptoms in animals, so detection requires testing for the presence of
the pathogen rather than just observation of the cattle.
APHIS officials said that APHIS does not have specific guidance on
STEC vaccines because it typically does not release such guidance for
a particular biological product until it has reviewed and approved
three applications, which gives the agency sufficient information to
provide specific guidance. They said that the agency's general vaccine
guidance offers it flexibility during the application review process
by not being too prescriptive on requirements. During the course of
our study, APHIS addressed some of the concerns we raised by releasing
a one-page summary on licensing of preslaughter vaccines for a public
meeting on food safety, but it still does not have documented guidance
on the application process, including requirements specifically for
these vaccines.
USDA Determined That Six Additional STEC Strains Were Adulterants and
Has Tests to Detect Them:
USDA determined that six additional STEC non-O157 strains were
adulterants in beef in September 2011, has developed a method to test
for them in beef, and plans to use this method starting in June 2012.
Commercial tests are also available, and a few companies are
voluntarily testing for these strains.
USDA Determined That Six Additional Strains Were Adulterants and Has
Tests to Detect Them, but It Can Be Difficult to Confirm Positive
Results:
In September 2011, USDA's FSIS announced that it determined that six
pathogenic strains of STEC--O26, O45, O103, O111, O121, and O145--were
adulterants in raw ground beef and beef trim (the meat left over after
steaks and roasts are carved from a side of beef), in addition to STEC
O157:H7. According to CDC, at least 150 STEC non-O157 strains have
been associated with illness, but the majority of those illnesses have
been traced to these six STEC non-O157 strains. There are several
consequences to these strains being adulterants, including the
following:
* Sale of beef contaminated with these strains is prohibited.
* Beef slaughter and processing plants must have a HACCP plan in place
to identify and control the strains and to verify that the methods
used to control the strains are working properly. Verification could
include testing, but testing is not mandatory.
* FSIS has more reason to routinely test a subset of products for
these strains and to request a recall for products deemed to be
adulterated.
According to a September 20, 2011, notice in the Federal Register,
[Footnote 7] FSIS intended to begin testing for these six strains in
samples of raw ground beef and beef trim at slaughter and processing
plants in March 2012, after it has reviewed comments from the public.
Subsequent to this notice, FSIS moved its test date to June 4, 2012.
In conducting these tests, FSIS plans to use a method developed by
USDA's ARS that was first published in October 2010 and revised in
November 2011. This method has two key phases: (1) preliminary
testing, which may take up to 2 days, and (2) isolation and
confirmation, which may take an additional 2 to 4 days. These two
phases are also used for STEC O157:H7 testing.
Preliminary testing involves two main steps. First, beef samples are
tested for two genes--known as stx and eae--that are known to make E.
coli pathogenic. Second, the samples are tested for other genes that
are specific to each of the six STEC non-O157 strains. Positive
results in both steps are considered a "potential positive," which
means the pathogen may be present. According to an ARS official, if
used as planned, preliminary tests for the six strains are reliable.
However, it is possible that these genes are present in a beef sample
but come from different strains of bacteria. It is, therefore,
necessary to isolate the suspect strain and confirm that it is the
source of the two genes that make E. coli pathogenic.
Several steps are involved in the isolation and confirmation phase;
two of these steps may be difficult and time-consuming, according to
ARS officials. The first involves separating the suspected strain of
pathogenic E. coli from other bacteria using immunomagnetic separation
beads that contain antibodies (components of the human immune system)
that adhere to a specific strain of E. coli. According to an ARS
official, it would be very difficult to isolate the target strain
without the use of these beads. However, the official also said that
the beads are not commercially available for two of the six strains--
O45 and O121. ARS currently buys beads from a commercial supplier for
the other four strains but has to make them for O45 and O121, which is
a time-consuming and costly process, according to an ARS official.
FSIS is currently searching for companies willing to produce beads for
the two strains and make them commercially available and, according to
an FSIS official, expects to have test manufacturers in place by June
2012.
The second step involves growing the target strain by placing the
immunomagnetic beads onto a solid growth medium containing a mix of
nutrients that is specific to this strain and suppresses the growth of
other bacteria. According to an ARS official, scientists allow the
bacteria sticking to the beads to grow and multiply on the medium,
using methods that ensure the bacteria form colonies that are all from
the same strain. This makes it easier to identify the target strain
and confirm that it has the two disease-causing genes--stx and eae.
However, according to the ARS official, some of the six STEC non-O157
strains may not always grow well on the medium that FSIS is currently
using. If the strains do not grow well, it will be difficult to
confirm potentially positive results and, consequently, beef samples
that contain one of the six pathogenic strains could incorrectly test
negative. According to the ARS official, a revised November 2011
testing method includes an improved growth medium for the six strains.
This official added that ARS has conducted various tests to find the
optimal growth medium for the six strains, and the medium FSIS is
using is the best currently available. Research is ongoing by ARS and
in the broader scientific community to develop a better growth medium,
according to this ARS official, and ARS will evaluate other mediums as
they become commercially available. See figure 3 for a summary of the
testing process.
Figure 3: Preliminary and Isolation and Confirmation Testing Phases
for the Six STEC Non-O157 Strains:
[Refer to PDF for image: illustration]
Preliminary testing:
Screen for the stx and eae genes.
Is the test positive for both genes?
No: Report as negative; test is complete;
Yes: Proceed to the second screening test.
Is the test positive for one of the six STEC non-0157 strains?
No: Report as negative; test is complete;
Yes: Continue.
Isolation and confirmation testing:
Separate the target strain with immunomagnetic separation beads.
Grow the strains attached to the immunomagnetic beads in a growth
medium and continue with confirmation.
Test is complete.
Source: GAO summary of USDA information.
Note: This figure shows the two main phases for E. coli detection
testing. For a comprehensive description of all of the detection
testing steps, see USDA's Microbiology Laboratory Guidebook MLG 5B.01.
[End of figure]
Commercial Tests Are Available and Some Companies Are Testing:
Preliminary tests to detect the six strains are commercially
available, and at least one test manufacturer sells these tests for
all six strains. ARS collaborated with this manufacturer to develop
the tests and is now collaborating with other manufacturers, many of
which became interested in developing tests after USDA's announcement
that it had determined to consider the six strains as adulterants,
according to an ARS official. A representative from one test
manufacturer told us he was confident that his company could produce
enough tests to meet the demand of the U.S. beef industry. Similarly,
a representative from a second manufacturer told us that it is
preparing to meet the demand.
Starting on June 4, 2012, FSIS will expect slaughter and processing
plants to have a plan in place to identify and control the six STEC
non-O157 strains. Such a plan may include information on how the plant
will use testing to verify that food safety systems are working
properly. FSIS officials estimate that about 20 percent of U.S.
slaughter plants are currently testing for STEC non-O157 strains,
although FSIS did not know for which specific strains these plants are
testing. Representatives from two beef processing plants--one of which
is also a retailer--told us that they are testing for all six strains.
The plant that is also a retailer will also require its beef suppliers
to test for these strains before it accepts the beef. The retailer
will also test for STEC O104, an additional STEC non-O157 strain, as
soon as a test is commercially available for beef. The representative
from this retailer did not report challenges with using the
commercially available preliminary test for the six strains. However,
commercial preliminary tests for the six strains are new, and
according to representatives from a test manufacturer, the
manufacturer recently started conducting field trials on the tests.
Both beef processing plants said they also carry out confirmation
tests for potential positive results through a third-party laboratory.
An official from one of these plants told us that he has not observed
any difficulty in growing the six strains after separation using the
commercially available growth mediums, but he noted confirmation of
potentially positive results for the six pathogenic strains can be a
time-consuming process. According to a test manufacturer
representative, confirmation of potentially positive results will
likely be difficult for the beef industry, for the same reasons it is
proving difficult for FSIS.
If a plant detects one of the six strains in ground beef or beef trim,
its response is generally dictated by FSIS requirements. Possible
responses to a positive test include disposing of the beef or cooking
it to kill bacteria.
Some Countries Have Practices That Could Be Relevant to U.S. Efforts
to Reduce STEC in Cattle:
Several researchers, U.S. agency officials, and a foreign government
official said that the United States is the leader in researching and
employing preslaughter interventions. USDA officials, however,
commented that they would consider preslaughter practices other
countries have conducted if they are relevant to U.S. efforts to
reduce STEC in cattle. The following are some practices other
countries have employed that may help reduce STEC in cattle and that
are not currently used in the United States:
Cattle cleanliness inspections. Several foreign governments conduct
cleanliness inspections that may reduce STEC in beef. For example,
European Parliament and the Council of the European Union regulations,
referenced by European Commission officials, require that (1) farmers
take adequate measures to ensure the cleanliness of cattle going to
slaughter, (2) operators of slaughter plants ensure cattle are clean
before accepting them, and (3) meat inspectors verify that the cattle
about to be slaughtered are clean. In the United Kingdom, meat
inspectors use a five-category rating system for cattle cleanliness
that ranges from "clean and dry" to "filthy and wet," according to a
2002 guidance document from the Food Standards Agency. Only cattle
rated in the two highest categories for cleanliness may proceed to
slaughter. In Australia, according to its standard for the hygienic
production and transportation of meat and meat products for human
consumption, an inspector must determine that cattle are clean prior
to slaughter. If they are not, they can be passed for slaughter
subject to conditions that ensure that they do not contaminate other
animals, carcasses, and carcass parts. According to New Zealand
government officials, their inspectors check for hide cleanliness to
help prevent meat contamination. In contrast, in the United States,
FSIS assesses the health of cattle prior to slaughter but does not
inspect for cleanliness.
Testing for STEC. At least 12 European Union member countries
collected and reported data on STEC in live cattle in 2009, according
to a 2011 European Food Safety Authority and European Centre for
Disease Prevention and Control report.[Footnote 8] Such data are
important to identify the main sources of infections. In countries
such as Sweden and Denmark, this testing is conducted regularly. For
example, in Sweden, government officials collect about 2,000 fecal
samples every 3 years, according to an official from Sweden's National
Veterinary Institute. These samples are collected at geographically
distributed slaughterhouses throughout Sweden. Sweden tests for STEC
O157:H7 and started to test 1,000 fecal samples for STEC O26 in its
2011 study. In Denmark, the National Food Institute collects fecal
samples from approximately 200 bulls per year to test for STEC
O157:H7, according to an institute official. In the United States,
APHIS has conducted feedlot studies that involved testing for STEC in
live cattle, but this testing was voluntary and last conducted in 1999.
Testing cattle from specific farms in Sweden. When a person becomes
ill from E. coli in Sweden, Swedish government officials try to
determine its source by interviewing this person, according to an
official from Sweden's National Food Administration. If this person is
suspected of having been in contact with cattle from a specific farm,
cattle from this farm will be sampled. If there is an E. coli strain
match with that of the ill person, this official said that Sweden's
Board of Agriculture would then recommend that the cattle from this
farm be slaughtered at a slower rate so that the carcasses can be
tested for STEC and heat-treated if found positive. Although this is a
recommendation, this official stated that its slaughterhouses follow
the board's recommendations. According to this official, since 1996,
Sweden has had 52 cases of human illnesses from STEC--46 from the
O157:H7 strain, 2 from O26, 2 from O121, 1 from O8, and 1 from O103.
In the United States, STEC O157:H7 in beef can be traced back to the
beef supplier, but USDA officials said that they do not trace the
source of the pathogen back to the farm and thus cannot make
recommendations for special testing from specific farms.
Conclusions:
Preslaughter interventions for cattle have the potential to help
reduce STEC-related illnesses, although they are unlikely to be able
to eliminate all pathogenic strains in cattle. USDA, the beef
industry, and university researchers have been working to develop
these interventions. Few manufacturers have submitted applications for
preslaughter intervention products to target STEC, but at least two
have submitted applications for STEC vaccines. However, the approval
requirements are unclear. In 2005, USDA's APHIS clarified its
responsibility for vaccines, but it still has not provided specific
guidance on the information it needs to approve a vaccine for STEC.
Without guidance that gives manufacturers clear and more specific
information they need to submit an acceptable application, the
approval requirements for STEC vaccines could face delays and thereby
increase the risk to public health. In addition, some countries have
employed practices not currently used in the United States that
potentially can inform U.S. efforts for reducing STEC in cattle.
Recommendations for Executive Action:
GAO recommends that the Secretary of Agriculture take the following
two actions:
* Direct the Administrator of APHIS to provide more specific public
guidance on the license approval requirements for STEC vaccines in
order to help improve clarity and reduce potential delays in the
application process for these vaccines.
* Explore practices employed by other countries that are not currently
used in the United States for reducing STEC in cattle and consider
whether the identified practices can inform U.S. efforts.
Agency Comments and Our Evaluation:
We provided a copy of our draft report to the Departments of
Agriculture and of Health and Human Services. In its written response,
USDA generally agreed with the information in the draft report. USDA
neither agreed nor disagreed with our recommendation that it provide
more specific public guidance on the license approval requirements for
STEC vaccines. USDA's APHIS acknowledged that additional public
guidance may be beneficial to applicants and stated that it is
committed to providing as much specific public guidance as possible.
However, APHIS stated that more specific requirements may discourage
product development efforts, and APHIS does not release specific
guidance about a new product until it has reviewed and approved at
least three applications. Further, according to industry
representatives, APHIS's approval requirements for STEC vaccines are
not clear. Our recommendation is intended to help improve clarity and
reduce potential delays in the application process for STEC vaccines.
As stated in our report, we found that guidance that does not give
manufacturers the information they need to submit an acceptable
application could delay the approval process. We also provided
examples of areas in which more specific guidance, such as clarifying
the term "clinically relevant efficacy," could reduce confusion. APHIS
addressed some of the concerns we raised by releasing a one-page
summary on licensing of preslaughter vaccines for a public meeting,
but this is not documented as guidance. We encourage APHIS to provide
more specific guidance that can reduce confusion without discouraging
product development of STEC vaccines. USDA agreed with our
recommendation to explore practices that are currently not used in the
United States for reducing STEC in cattle and consider whether the
identified practices can inform U.S. efforts. USDA's letter is
presented in appendix II. The Department of Health and Human Services
did not comment on the draft report but provided technical comments.
As appropriate, we incorporated these technical comments and those
provided by USDA.
This report is intended for use by USDA management. We are sending
copies of this report to the appropriate congressional committees and
members, the Secretary of Health and Human Services, and other
interested parties. In addition, this report is available at no charge
on the GAO website at [hyperlink, http://www.gao.gov].
We acknowledge and appreciate the cooperation and assistance provided
by USDA management and staff during our audit. If you have questions
about this report, please contact me at (202) 512-3841 or
shamesl@gao.gov. Contact points for our Offices of Congressional
Relations and Public Affairs may be found on the last page of this
report. GAO staff who made key contributions to this report are listed
in appendix III.
Sincerely yours,
Signed by:
Lisa Shames:
Director, Natural Resources and Environment:
[End of section]
Appendix I: Objectives, Scope, and Methodology:
Our objectives were to determine (1) preslaughter interventions that
may help reduce Shiga toxin-producing Escherichia coli (STEC) in
cattle; (2) the U.S. Department of Agriculture's (USDA) role in
approving STEC vaccines; (3) the extent to which STEC strains have
been determined to be adulterants in beef and the status of tests to
detect them; and (4) practices, if any, other countries have employed
that could reduce STEC in cattle and may be relevant to U.S. efforts.
For all four objectives, we visited several cattle feedlots and a
cattle slaughter plant in Colorado, which we selected because it is
one of the largest beef-producing states. While in Colorado, we also
interviewed USDA officials, beef industry representatives, and
university researchers. In addition, in a nonprobability sample, we
conducted a total of 71 interviews with USDA, Centers for Disease
Control and Prevention (CDC), and Food and Drug Administration (FDA)
officials; foreign government officials; beef industry
representatives; manufacturers of animal health products; federal and
university researchers; and consumer group representatives with
expertise in STEC in cattle. Our questions included descriptions of
preslaughter interventions, roles of federal government in
preslaughter interventions, and practices other countries have
employed to reduce STEC in cattle that may be relevant to U.S.
efforts. Because this was a nonprobability sample, the results cannot
be generalized to the entire United States, but they can provide
examples of research conducted on preslaughter interventions.
To determine the preslaughter interventions that may help reduce STEC
in cattle, we reviewed USDA and academic studies on preslaughter
interventions, reviewed USDA documents on funding for STEC research,
and met with USDA and university researchers and beef and
pharmaceutical industry representatives. We identified these studies
through interviews with USDA and university researchers.
To determine USDA's role in approving STEC vaccines, we reviewed USDA
guidance, and interviewed USDA officials, manufacturers of animal
health products, and university researchers.
To determine the extent to which STEC strains have been determined to
be adulterants in beef and the status of tests to detect them, we
reviewed USDA documents on STEC detection tests and interviewed FDA
and USDA officials, beef industry representatives, and detection test
manufacturers.
To determine practices, if any, other countries have employed that
could reduce STEC in cattle and may be relevant to U.S. efforts, we
interviewed CDC, FDA, and USDA officials; beef industry
representatives; university researchers; and consumer group
representatives to determine if they were aware of any such practices.
We also reviewed international studies, guidance, and requirements for
food safety in beef and interviewed international food safety
officials. We did not independently verify statements of foreign law.
We conducted this performance audit from January 2011 to March 2012 in
accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe
that the evidence obtained provides a reasonable basis for our
findings and conclusions based on our audit objectives.
[End of section]
Appendix II: Comments from the U.S. Department of Agriculture:
USDA:
United States Department of Agriculture:
Office of the Secretary:
Washington, DC. 20250:
February 23, 2012:
Ms. Lisa Shames:
Director:
Natural Resources and Environment:
United States Government Accountability Office:
441 G Street, NW:
Washington, D.C. 20548:
Dear Ms. Shames:
The United States Department of Agriculture (USDA) has reviewed the
U.S. Government Accountability Office's (GAO) draft report, "Food
Safety: Pre-Slaughter Interventions Could Reduce E. coli in Cattle"
(12-257). USDA generally agrees with the information provided in the
GAO draft report.
While reducing E. coli contamination cuts across several USDA
agencies, the Animal and Plant Health Inspection Service's (APHIS)
Center for Veterinary Biologics has the lead responsibility for
vaccine approval. As stated in the report, APHIS does not release
guidance specific about a new product until it has reviewed and
approved at least 3 applications. This provides for flexibility in how
each new product is evaluated and takes into account the "state of the
science" in determining the proper regulatory standards to apply.
Product-specific issues, most notably identifying a path to licensure,
and determining what type of data is most suitable for demonstrating
the purity, safety, potency, and efficacy of a product have
historically been handled through official correspondence between the
agency and the applicant. Most—-if not all-—of this information is
proprietary and highly confidential, thus, APHIS' guidance, in this
regard, is confidential as well.
While APHIS does not disagree that additional public guidance related
to these products may be beneficial to both the current applicants
(one of which has a license for their product) and future applicants
who have not yet brought new interventions forward, how best to
provide that guidance will need to be carefully considered. Unlike
many regulatory agencies (such as the Food and Drug Administration
(FDA), the European Medicines Agency, etc.), APHIS manages licensing
applications through an iterative process. APHIS does not generally
attempt to review applications in total, rejecting them if a specific
part is found lacking. Rather, APHIS works with manufacturers to
identify licensing issues and provides specific guidance to address
the specific issue that they have encountered to ensure that pure,
safe, potent, and effective products are brought to market consistent
with our mandate under the Virus-Serum-Toxin Act. Regardless, APHIS is
committed to providing as much specific public guidance as possible in
order to better inform industry.
In response to Recommendation #1, in APHIS' experience, the general
guidance that is currently in the public domain provides the basic
framework for the licensing of most of the products that are currently
on the market. More specific requirements that attempt to address some
of the challenges noted with E. tali 0157:H7 may in fact discourage
product development efforts unless the standards are appropriately
established. Of course, standards that are set too low support neither
animal health nor public health by extension.
APHIS will continue to use a variety of forums to provide licensing
information and guidance for these types of products to a broad group
of stakeholders. The Agency remains an active member of the 'E. colt
Coalition' led by the National Cattlemen's Beef Association (NCBA), by
providing information and updates at NCBA meetings; continuing to
engage the biologics industry associations in forums designed to
clarify any questions around licensing pathways; providing detailed
and specific guidance to manufacturers, licensees, and permittees on
individual submissions and studies presented to APHIS to support
licensing requirements; working with other USDA agencies, such as the
Food Safety and Inspection Service; and lastly, working with Federal
counterparts, like the FDA, on specific and broader intervention
possibilities.
In response to Recommendation #2, USDA agrees with this
Recommendation. USDA, specifically APHIS, will explore practices
employed by other countries that are not currently used in the United
States for reducing pathogenic E. coil in cattle, and will consider
whether those practices can inform U.S. efforts. USDA will also
continue its other efforts to explore and enhance pre-slaughter
interventions, such as the 2011 public meeting, jointly held by APHIS,
PSIS, and the Agricultural Research Service, to discuss how pre-
harvest pathogen control strategies for animals presented for
slaughter can reduce the likelihood that beef could become
contaminated with Shiga toxin-producing E. coil, Salmonella, and other
pathogens.
Thank you for the opportunity to comment on this draft report.
Sincerely,
Signed by:
Thomas J. Vilsack:
Secretary:
[End of section]
Appendix III: GAO Contact and Staff Acknowledgments:
GAO Contact:
Lisa Shames, (202) 512-3841, or shamesl@gao.gov:
Staff Acknowledgments:
In addition to the individual named above, Thomas Cook, Assistant
Director; Kevin Bray; Mark Braza; Christina E. Bruff; Allen T. Chan;
Barbara El Osta; Brenda Muñoz; Katherine M. Raheb; Sushil Sharma;
Benjamin Shouse; Carol Herrnstadt Shulman; and Kiki Theodoropolous
made key contributions to this report.
[End of section]
Footnotes:
[1] According to FSIS, thorough cooking of ground beef to an internal
temperature of 160° F throughout kills STEC O157:H7.
[2] See most recently in GAO, Federal Food Safety Oversight: Food
Safety Working Group Is a Positive First Step but Governmentwide
Planning Is Needed to Address Fragmentation, [hyperlink,
http://www.gao.gov/products/11-289] (Washington, D.C.: Mar. 18, 2011).
[3] GAO, Food Safety: The Agricultural Use of Antibiotics and Its
Implications for Human Health, [hyperlink,
http://www.gao.gov/products/GAO/RCED-99-74] (Washington, D.C.: Apr.
28, 1999). For more information about the use of antibiotics in
animals, see GAO, Antibiotic Resistance: Agencies Have Made Limited
Progress Addressing Antibiotic Use in Animals, [hyperlink,
http://www.gao.gov/products/GAO-11-801] (Washington, D.C.: Sept. 7,
2011).
[4] Conditional licenses are effective for a finite period, usually 1
year and may be renewed at the discretion of APHIS. The data required
for conditional licensure are reduced from that needed for full
licensure in that there needs only to be a "reasonable expectation" of
efficacy as defined by APHIS. Conditional licenses are not required
prior to receiving a full license but can be used to bring a product
to market. For example, the conditional license for the STEC O157:H7
vaccine allows cattle producers to use the vaccine under the
supervision of a veterinarian.
[5] Animal and Plant Health Inspection Service, USDA, Center for
Veterinary Biologics Notice No. 05-07 (Mar. 4, 2005).
[6] APHIS's general guidance includes Veterinary Services Memorandum
No. 800.202 and No. 800.204.
[7] 76 Fed. Reg. 58,157 (Sept. 20, 2011).
[8] European Food Safety Authority, European Centre for Disease
Prevention and Control; The European Union Summary Report on Trends
and Sources of Zoonoses, Zoonotic Agents and Food-borne Outbreaks in
2009; EFSA Journal 2011 (Parma, Italy: Mar. 22, 2011).
[End of section]
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